A video clip detailing the patient journey on the day of oocyte retrieval in addition to the standard of care: a randomized controlled trial

Abstract

STUDY QUESTION Can a video clip detailing the patient journey decrease women’s anxiety on the day of their first oocyte retrieval? SUMMARY ANSWER The video clip does not affect women’s anxiety on the day of their first oocyte retrieval. WHAT IS KNOWN ALREADY IVF triggers anxious reactions in women and men, with peaks of anxiety on the day of (especially the first) oocyte retrieval as shown by reliable questionnaires and biomarkers of distress. Several trials showed that videos with preparatory information reduce women’s and men’s anxiety for out-patient procedures. STUDY DESIGN, SIZE, DURATION This monocentric open-label randomized controlled trial (RCT) randomized (computerized 1:1 allocation) 190 heterosexual couples about to start their first IVF cycle during a 24 months’ recruitment period (2018–2020). In addition to the standard of care offered to both the intervention group and the control group, the intervention group received a video clip, the day prior to their first oocyte retrieval, detailing the patient journey on the day of oocyte retrieval. After completion of the RCT, 35 additional couples were recruited as part of a qualitative process evaluation (QPE). PARTICIPANTS/MATERIALS, SETTING, METHODS Upon arrival at a private secondary care fertility centre in Belgium for their first oocyte retrieval, women and men independently filled out the State module of the ‘State-Trait Anxiety Inventory’ (STAI) and the ‘Infertility-Specific Distress Scale’ (IDS) and evaluated the novel intervention, if applicable. In addition, clinical and discontinuation outcomes were extracted from couples’ electronic medical records 24 months later. The data of 155 couples (76–79/group) were subjected to an intention-to-treat analysis. The 35 couples taking part in the QPE filled out two questionnaires assessing knowledge and, if applicable, took part in an in-depth interview on their experience watching the video clip, immediately before their first oocyte retrieval. MAIN RESULTS AND THE ROLE OF CHANCE The video clip did not affect women’s anxiety on the day of oocyte retrieval (mean STAI-State score intervention group = 42.7 ± 8.1 vs control group = 42.1 ± 8.5, P = 0.68). Men who watched the video clip were, however, significantly less anxious than men who did not watch it (35.8 (±6.4) vs 38.2 (±7.6), P = 0.034). Surprisingly, infertility-specific distress was higher among women and men who watched the video clip, as compared to women and men who did not watch the video clip (mean Infertility-specific Distress (IDS) scale score for women, 25.8 (±4.9) vs 24.3 (±4.6), P = 0.051; men, 22.6 (±5.0) vs 20.8 (±4.7), P = 0.023). The QPE clarified that watching the video clip did not increase knowledge about what would happen but that some women and men found the visualization of invasive procedural steps more confrontational than the earlier received, abstract, written, and verbal information. All but one woman and all men in the intervention group would recommend the video clip to friends and family going through IVF. The intervention and control groups did not differ regarding secondary clinical and discontinuation outcomes. LIMITATIONS, REASONS FOR CAUTION Due to the nature of the intervention it was not possible to blind the participants. Furthermore, we did not have an attention control group, which could have separated plausible benefits of the intervention from attentional effects, although limiting performance bias in educational intervention studies is difficult as study personnel cannot be blinded. Of note, this RCT was partially conducted during the COVID-19 pandemic; thus, postponement of the oocyte retrieval and plausible side effects of the pandemic itself might have impacted our results, but group differences are corrected by the randomized controlled design of our trial. WIDER IMPLICATIONS OF THE FINDINGS Providing additional procedural information is interesting for clinics as patients recommended the video clip and as it decreased men’s anxiety on the day of couples’ first oocyte retrieval. The effect of the intervention was observed in a Dutch-speaking population, and investigating beneficial effects of the video clip in non-native speakers and patients with a lower education or literacy level may be of interest, as they are more prone to health information overload and often benefit from visual rather than verbal or written information. STUDY FUNDING/COMPETING INTEREST(S) This research was supported by the Research Council of the KU Leuven (C14/18/106; project of J.V., K.P., and E.A.F.D.) and it is an Investigator Sponsored Study for Merck N.V./S.A., an affiliate of Merck KGaA, Darmstadt, Germany. Merck N.V./S.A. had no ultimate authority nor any other role in the design, data collection, data management, data analysis, data processing, data interpretation, and on the decision to submit this study for publication. T.M.D. is vice president and Head of Global Medicine Affairs Fertility, Research and Development, Merck Healthcare KGaA, Darmstadt, Germany. He is also a visiting professor in Reproductive Medicine and Biology at KU Leuven, Belgium and an adjunct professor at the Department of Obstetrics and Gynecology at the University of Yale, New Haven, USA. Neither his corporate role nor his academic roles represent a conflict of interest with respect to the work done by him for this study. The other co-authors have no conflict of interest. TRIAL REGISTRATION NUMBER This trial is registered at clinicaltrials.gov as NCT03717805. TRIAL REGISTRATION DATE 10 October 2018 DATE OF FIRST PATIENT’S ENROLMENT 29 October 2018